The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Capable of understanding and signing the informed consent. Willing to comply with the study requirements;

Serum HBsAg positive and ALT<10ULN at study screening;

Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion Criteria:

History of viral breakthrough or genotypic resistance on previous therapy;

History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;

Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;

Other protocol defined exclusion criteria.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341743

Locations

China, Beijing

Beijing Ditan Hospita

Beijing, Beijing, China

Beijing Friendship Hospital Attached to the Capital Medical University

Beijing, Beijing, China

Department of infectious disease, First Hospital of Peking University

BeiJing, Beijing, China

People'S Hospital Under Beijnig University

Beijing, Beijing, China

China, Fujian

The First Affiliated Hospital of Fujian Medical University

FuZhou, Fujian, China

China, Guangdong

The First People's Hospital of Foshan

FoShan, Guangdong, China

Department of infectious disease, Nanfang Hospital

GuangZhou, Guangdong, China

GuangDong Provincial People's hospital

GuangZhou, Guangdong, China

China, Guangxi

First Affiliated Hospital of Guangxi Medical University

NanNing, Guangxi, China

China, Hubei

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology